• Start-up Specialist II

    Job Location(s) UK-Maidenhead
    Job Number
    Job Category
    Hidden (54286)
    Position Type
  • Job Overview

    This is an Office Based Role (at junction 4 of tne M3) with a top pharmaceutical company, working in a fast paced dynamic environment focusing on UK and Ireland Clinical Study Start Up. There will be some flexibility to work from home on an ad hoc basis.


    Later in 2019 the office is re-locating to West London. Currently it is based in Camberley in Surrey (Frimley Business Park)


    Company officially certified by the Top Employers Institute for its exceptional employee offerings and has been voted Top European Employer


    Wide Therapy Area within General Medicine and Oncology


    Competitive salary and benefits


    Full support and a focus on development


    Free access to training


    Great team of people


    Would suit an in house CRA or start up specialist who has experience of Costing Template, Ethics Submissions, R and D (IRAS), site liaison, feasibility, contracts.


    Will consider 4 days/week or full time


    Permanently EMPLOYED by Covance and contracted out to a top ten pharmaceutical company


    Job Purpose


    To provide an efficient and professional ethics and R&D set up service within required timelines according to company SOPs and ICH GCP guidelines and to provide advice and knowledge to project managers and clinical associates regarding the ethics / regulatory processes in the UK and Republic of Ireland.


    Major Accountabilities


    Accountable for rapid study set up for all clinical trials across UK Operations and ensures that they are provided with a first in class study set up service.

    Works closely with Clinical Set Up and Logistics Manager to identify process improvements for a more efficient service of ethics and trial set up.

    Advises clinical project teams and department with regards to new processes and procedures concerning ethics and R&D processes and advises Project Managers and field based CRAs on submission timelines.

    Proof reads ethics submissions and documentation for Clinical Project Managers and liaises with Medical Advisers when needed.

    Takes the lead on new Regulatory department processes and trains team appropriately.

    Performs site monitoring activities such as unmasked monitoring and site drug supply management when required.

    Collates, prepares and submits REC and SSI applications to the earliest possible review meetings following NRES and ICH GCP and collates, prepares and completes R&D applications for R&D submissions during trial set up period.

    Is responsible for contract / budget negotiations with R&D/PCTs for ICRO clinical trials

    Responsible for clinical trial set up, facilitates preparation and collection of country and site level documentation to ensure drug shipment without delay.

    Is accountable for timely distribution of trial safety data for specified products as per regulatory requirements to ethics and R&D departments and well as the submssion progress and end of study clinical reports to SOPs and NIPs and local authority requirements

    Liaises with Global interfaces and other departments to ensure correct reporting documentation is received for submission


    The role would suit candidates who are particularly interested in study start up activities in the UK and Republic of Ireland. If you have awareness of the current MHRA regulations for ethics submissions and R and D approvals this will be a major advantage in your application.


    We particularly welcome applicants from within the NHS who have clinical trials start up expertise in perhaps a governance role and who are looking to make the move into commercial pharma operations.You may have been a study site coordinator or clinical trials coordinator for example OR research nurse OR perhaps a CRA who is now looking for an office based role with minimal travel


    We definitely need someone who can work autonomously and be accountable/responsible for a successful site activation. You must be an excllent communicator with good negotiation skills and a drive for success.




    key words study start-up, CTA. clinical set-up, IRAS, ethics, regulatory, clinical trials administration, clinical project associate, clinical trials associate, clinical documentation specialist, site activation, site initiation


    Please call Marc Joseph on 01753 216664 to explore this further or alternatively email with ypour CV and application.

    Education / Qualifications

    We are looking for someone who has experience in the start up environment already. This is not a trainee role.


    Ideally we would like someone who has a "similar" profile to that outlined below:-


    1.Completing IRAS, HRA and R&D submissions for new clinical trials.

    2.Negotiating site contracts and budgets.

    3.Collecting, reviewing, processing and tracking regulatory & investigator documents required for study site activation in accordance with company and Sponsor SOPs, ICH GCP guidelines, EU Clinical Trials Directives, FDA Regulations and the Investigator Package Plan.

    4.Reviewing of patient information sheets and informed consents for compliance to international and country requirements and protocol.

    5.Preparing, reviewing and submitting initial and amended submissions to Research Ethics Committees.

    6.Assessing impact of site personnel changes and/or study amendments on regulatory documents and process/review new documents according to ICH/GCP guidelines.

    7.Communicating regularly with start-up and clinical project managers, clinical trial leads, CRAs and CTAs via site status reports, CTMS, phone and email.

    8.Liaising directly with Sponsor local affiliates regarding site progress, contracts and budgets


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